Heart occlusion devices

• US 9,770,232 B2
• Filed: 08/09/2012
• Issued: 09/26/2017
• Est. Priority Date: 08/12/2011
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Amin, Zahid, Cully, Edward H., Cutright, Warren, Larsen, Coby, Masters, Steven J., Shaw, Edward Emil
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US13/571,046
• Publication Number:
  US 20130041404A1
• Time in Patent Office: 1,874 Days
• Field of Search: 606213, 606215-219, 606200, 606151, 606153, 606157, 606139, 606232, 2271751, 227 1, 2271791, 2271811, 227 26, 227 28, 227 29, 227 30, 227 31, 227 19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

Devices for occluding an aperture in tissue or a vessel include a first flexible wire and a second flexible wire. Each of the first and second wires is formed of a shape memory material. Each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane. The first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire. Methods for occluding an aperture in tissue or a vessel using such devices are also provided.

Claims

1. A device for occluding an aperture in tissue or a vessel, the device comprising:

a hub aligned with a central axis of the device and configured to removably attach to a deployment tool for deploying the device at the aperture;

a first flexible wire attached to the hub and a second flexible wire attached to the hub, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into a first geometric form, a second geometric form, and a third geometric form, such that, in a deployed configuration, the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and the third geometric form of the first wire and the third geometric form of the second wire form a third plate in a third plane that is parallel to and remote from both the first and second planes, and the first and second plates are separated by a first waist formed from two portions of the first wire and two portions of the second wire, and the second and third plates are separated by a second waist formed from an additional two portions of the first wire and an additional two portions of the second wire, and the two portions of the first wire and the two portions of the second wire each include a first curvature and a first length, the additional two portions of the first wire and the additional two portions of the second wire each include a second curvature and a second length, the first length differs from the second length, and the first curvature differs from the second curvature, and

wherein the additional two portions of the first wire and the additional two portions of the second wire of the first waist and the second waist are substantially centered about a longitudinal axis of the device in the deployed configuration.

2. The device of claim 1, wherein at least two of the first plate, the second plate, and the third plate are of unequal sizes.

3. The device of claim 2, wherein the first plate, the second plate, and the third plate are each of unequal sizes.

4. The device of claim 3, wherein the second plate is larger than the first plate.

5. The device of claim 3, wherein the third plate is larger than the second plate.

6. The device of claim 1, wherein the first plate, the second plate, and the third plate are of equal sizes.

7. The device of claim 1, wherein the first plate has a first surface area;

and

the second plate has a second surface area that is larger than the first surface area.

8. The device of claim 7, wherein the third plate has a third surface area that is larger than the second surface area.

9. The device of claim 1, wherein the first plate has a first diameter;

and

the second plate has a second diameter that is larger than the first diameter.

10. The device of claim 9, wherein the third plate has a third diameter that is larger than the second diameter.

11. The device of claim 1, wherein the first, second, and third and second geometric forms of the first and second wires are generally semi-circular.

12. The device of claim 1, wherein:

the first plate comprises a first disc;

the second plate comprises a second disc; and

the third plate comprises a third disc.

13. The device of claim 1, further comprising:

a covering arranged on the first plate.

14. The device of claim 1, further comprising:

a covering arranged on the second plate.

15. The device of claim 1, further comprising a covering arranged on the first plate and the second plate.

16. The device of claim 15, wherein the covering comprises polytetrafluoroethylene.

17. The device of claim 1, wherein the aperture is a defect selected from the group consisting of a PFO, an ASD, a VSD, and a PDA.

18. The device of claim 1, wherein the aperture is in an artery, vein or atrial appendage.

19. The device of claim 1, further comprising at least one delivery attachment hub, wherein the hub is attached to one or more ends of the first and second wires.